BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION

BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION is an FDA 510(k)-cleared medical device (K903360) manufactured by Augustine Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 1990. Regulation: 8.